Study to Assess Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.
2026年9月11日 更新者：Sanofi
A Phase 1/2, Parallel, Observer-blind Study to Assess the Safety and Immunogenicity of an Egg-based H5N8 Influenza Vaccine at Multiple Dose Levels Adjuvanted With Matrix-M in Healthy Participants 18 Years of Age and Above.
The study aims to evaluate an egg-based H5N8 influenza vaccine up to 3 dose levels (low, medium, and high dose) given with or without adjuvant to see if the adjuvant improves vaccine effectiveness.
The study will enroll healthy adults aged 18 years and over. Participants will receive 2 injections in their arm of either one of the 3 dose levels of the study vaccine (low, medium, or high dose) with the adjuvant or the unadjuvanted vaccine (high dose).
Study duration per participant: approximately 14 months (including screening visit).
調査の概要
状態
募集
研究の種類
介入
入学 (推定)
640
段階
- フェーズ2
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Trial Transparency email recommended (Toll free for US & Canada)
- 電話番号：option 6 800-633-1610
- メール：contact-us@sanofi.com
研究場所
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Arizona
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Tempe、Arizona、アメリカ、85281
- 募集
- AMR Clinical Phoenix, Arizona- Site Number : 8400004
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California
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Rolling Hills Estates、California、アメリカ、90274
- 募集
- Peninsula Research Associates- Site Number : 8400011
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San Diego、California、アメリカ、92123
- 募集
- California Research Foundation- Site Number : 8400007
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Florida
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Coral Gables、Florida、アメリカ、33134
- 募集
- Alliance for Multispeciality Research - Coral Gables- Site Number : 8400003
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DeLand、Florida、アメリカ、32720
- 募集
- Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400017
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Fort Myers、Florida、アメリカ、33912
- 募集
- Alliance for Multispeciality Research - Fort Myers- Site Number : 8400001
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Miami Lakes、Florida、アメリカ、33016
- 募集
- Indago Research & Health Center- Site Number : 8400010
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Georgia
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Decatur、Georgia、アメリカ、30030
- 募集
- Accel Research Sites - NeuroStudies- Site Number : 8400014
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Decatur、Georgia、アメリカ、30030
- 募集
- iResearch Atlanta- Site Number : 8400008
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Illinois
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Oak Brook、Illinois、アメリカ、60523
- 募集
- AMR Chicago- Site Number : 8400005
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Kansas
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Newton、Kansas、アメリカ、67114
- 募集
- AMR Clinical Newton, Kansas- Site Number : 8400006
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New York
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Rochester、New York、アメリカ、14609
- 募集
- Rochester Clinical Research- Site Number : 8400012
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South Carolina
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North Charleston、South Carolina、アメリカ、29405
- 募集
- Coastal Carolina Research Center - North Charleston- Site Number : 8400018
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Tennessee
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Knoxville、Tennessee、アメリカ、37909
- 募集
- Alliance for Multispecialty Research - Weisgarber Medical Park- Site Number : 8400002
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Utah
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Salt Lake City、Utah、アメリカ、84107
- 募集
- CenExel JRB - Salth Lake City- Site Number : 8400009
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Virginia
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Charlottesville、Virginia、アメリカ、22911
- 募集
- Charlottesville Medical Research- Site Number : 8400016
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria:
- Aged 18 years or above on the day of inclusion
- Participants who are healthy as determined by medical evaluation including medical history
- Not pregnant/breastfeeding; non-childbearing potential or uses effective contraception/abstinence from ≥4 weeks before the first study intervention dose to ≥8 weeks after the last dose
- Informed consent form has been signed and dated
- Able to attend all scheduled visits and to comply with all study procedures
- Covered by health insurance, if required by local regulations
Exclusion Criteria:
- Known or suspected immunodeficiency; immunosuppressive therapy in past 6 months; or long-term systemic corticosteroid (eg, prednisone for more than 2 weeks in the past 3 months)
- Known hepatitis B or hepatitis C infection (based on medical history)
- Known personal or family history of previous episodes of Guillan-Barré syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
- Known systemic hypersensitivity to any of the study intervention components or history of life-threatening reaction to the study interventions or products with same substances
- Self-reported thrombocytopenia contraindicating intramuscular (IM) injection based on investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection based on investigator's judgment
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- History of A/H5 infection prior to the study participation
- Moderate or severe acute illness/infection (per investigator judgment)/fever (≥ 38.0°C [≥ 100.4°F]) on study intervention day. Include participant only after the condition or fever has resolved
- Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
- Any vaccine given 4 weeks before first study intervention or any planned vaccination to be given prior to Day 43 (ie, approximately 21 days after the second study intervention)
- Previous vaccination against A(H5) with an investigational or marketed vaccine. This includes, but is not limited to, influenza subtypes A(H5N1), A(H5N8), and A(H5N6)
- Has received a blood transfusion or blood-derived products, including immunoglobulins in the past 3 months
- Participation in another clinical study for a vaccine, drug, medical device, or medical procedure within 4 weeks before enrollment or planned participation during the present study period
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Is an investigator, investigator/study center employee, or immediate family member (parent, spouse, natural/adopted child) of the investigator/employee with direct involvement in the study
- Any screening safety laboratory parameters out of normal ranges and assessed as > Grade 2
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Group 1: Flu H5 egg pandemic low dose vaccine, with adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic low dose vaccine, with adjuvant
|
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
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実験的：Group 2: Flu H5 Egg Pandemic medium dose vaccine, with adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic medium dose vaccine, with adjuvant
|
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
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実験的：Group 3: Flu H5 Egg Pandemic high dose vaccine, with adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic high dose vaccine, with adjuvant
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Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
|
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実験的：Group 4: Flu H5 Egg Pandemic high dose vaccine, without adjuvant
Participants receive 2 intramuscular injections of flu H5 egg pandemic high dose vaccine, without adjuvant
|
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of participants with immediate Adverse Events (AEs)
時間枠：Within 30 minutes after each vaccination
|
Immediate adverse events are medically relevant unsolicited systemic adverse events reported in the 30 minutes after vaccination
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Within 30 minutes after each vaccination
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Number of participants experiencing solicited administration site reactions (pre-listed in the participant diary and case report form [CRF])
時間枠：Within 8 days of each vaccination, including the day of vaccination
|
A solicited reaction is an adverse reaction (sign or symptom) observed and reported under the conditions pre-listed (for example: injection site pain or headache).
Solicited administration site reactions are reactions at and around the injection/administration site
|
Within 8 days of each vaccination, including the day of vaccination
|
|
Number of participants experiencing solicited systemic reactions (pre-listed in the participant diary and CRF)
時間枠：Within 8 days of each vaccination, including the day of vaccination
|
All solicited reactions that are not solicited injection or administration site reactions
|
Within 8 days of each vaccination, including the day of vaccination
|
|
Number of participants experiencing unsolicited AEs
時間枠：Within 21 days after the first vaccination, including the day of the first vaccination, and within 28 days after the second vaccination, including the day of the second vaccination
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Unsolicited AE: an observed AE that does not fulfill the conditions of solicited reactions
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Within 21 days after the first vaccination, including the day of the first vaccination, and within 28 days after the second vaccination, including the day of the second vaccination
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Number of participants experiencing Medically Attended Adverse Events (MAAEs)
時間枠：From Day 01 until the end of the study, approximately 14 months
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MAAEs are collected throughout the study
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From Day 01 until the end of the study, approximately 14 months
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Number of participants experiencing Adverse Events of Special Interest (AESIs)
時間枠：From Day 01 until the end of the study, approximately 14 months
|
AESIs are collected throughout the study
|
From Day 01 until the end of the study, approximately 14 months
|
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Number of participants experiencing Serious Adverse Events (SAEs)
時間枠：From Day 01 until the end of the study, approximately 14 months
|
SAEs are collected throughout the study
|
From Day 01 until the end of the study, approximately 14 months
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Number of participants experiencing out-of-range biological test results (including shift from baseline values)
時間枠：Up to 8 days after each vaccination
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Safety laboratory assessments will include clinical chemistry and hematology
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Up to 8 days after each vaccination
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Number of participants experiencing AEs leading to discontinuation
時間枠：From Day 01 until the end of the study, approximately 14 months
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AEs leading to discontinuation are collected throughout the study
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From Day 01 until the end of the study, approximately 14 months
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Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer
時間枠：Day 01 and Day 43
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Influenza vaccine antibody titers are measured by HAI assay
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Day 01 and Day 43
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Number of participants with HAI Ab titer ≥ 40 (1 dilution [dil]; ie, seroprotection)
時間枠：Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
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Day 43
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Number of participants with seroconversion
時間枠：Day 01 and Day 43
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Seroconversion is defined as HAI Ab titer < 10 (1/dil) on Day 01 and post-injection titer ≥ 40 (1/dil) on Day 43; or defined as HAI Ab titer ≥ 10 (1/dil) on Day 01 and a ≥ 4-fold increase in titer (1/dil) on Day 43
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Day 01 and Day 43
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Geometric mean titer ratio of individual HAI Ab titer ratio Day 43/Day 01
時間枠：Day 01 and Day 43
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01 and Day 43
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Geometric mean titer of hemagglutination inhibition (HAI) assay antibody (Ab) titer obtained on Day 01, Day 22, Day 43, Day 202
時間枠：Day 01, Day 22, Day 43, Day 202
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01, Day 22, Day 43, Day 202
|
|
Geometric mean titer ratio of individual HAI Ab titer ratios Day 22/Day 01, Day 43/Day 01, Day 202/Day 43
時間枠：Day 01, Day 22, Day 43, Day 202
|
Individual HAI Ab titer ratios are calculated for the following time points: Day 22/Day 01, Day 43/Day 01 and Day 202/Day 43
|
Day 01, Day 22, Day 43, Day 202
|
|
Number of participants with individual HAI Ab titer ≥ 40 (1/dil) on Day 01, Day 22, Day 43, Day 202
時間枠：Day 01, Day 22, Day 43, Day 202
|
Influenza vaccine antibody titers are measured by HAI assay
|
Day 01, Day 22, Day 43, Day 202
|
|
Number of participants with seroconversion on Day 22 compared to Day 01 (baseline)
時間枠：Day 01, Day 22
|
Seroconversion is defined as titer < 10 (1/dil) on Day 01 and post-injection titer ≥ 40 (1/dil) on Day 22; or defined as titer ≥ 10 (1/dil) on Day 01 and a ≥ 4 fold increase in titer (1/dil) on Day 22
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Day 01, Day 22
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Number of participants with detectable HAI Ab titer
時間枠：Day 01, Day 22, Day 43, Day 202
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Detectable HAI Ab titer: a titer ≥ 10 (1/dil)
|
Day 01, Day 22, Day 43, Day 202
|
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Geometric mean titer of neutralization (NT) Ab titer
時間枠：Day 01, Day 22, Day 43, Day 202
|
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
|
Day 01, Day 22, Day 43, Day 202
|
|
Geometric mean titer ratio of individual NT Ab titer ratio
時間枠：Day 01, Day 22, Day 43, Day 202
|
Individual NT Ab titer ratios are calculated for the following time points: Day 22/Day 01, Day 43/Day 01 and Day 202/Day 43
|
Day 01, Day 22, Day 43, Day 202
|
|
Number of participants with NT Ab titer ≥ 20 (1/dil)
時間枠：Day 01, Day 43, Day 202
|
NT Ab titer ≥ 20 (1/dil) on Day 43; compared to Day 01 and Day 202
|
Day 01, Day 43, Day 202
|
|
Number of participants with NT Ab titer ≥ 40 (1/dil)
時間枠：Day 01, Day 43, Day 202
|
NT Ab titer ≥ 40 (1/dil) on Day 43; compared to Day 01 and Day 202
|
Day 01, Day 43, Day 202
|
|
Number of participants with NT Ab titer ≥ 80 (1/dil)
時間枠：Day 01, Day 43, Day 202
|
NT Ab titer ≥ 80 (1/dil) on Day 43; compared to Day 01 and Day 202
|
Day 01, Day 43, Day 202
|
|
Geometric mean fold-rise of fold increase in NT Ab titer [post/pre] ≥ 2 and ≥ 4
時間枠：Day 43
|
Influenza vaccine antibody titers are measured by serum neutralization (SN) assay
|
Day 43
|
|
Number of participants with detectable NT Ab titer
時間枠：Day 01, Day 22, Day 43, Day 202
|
Detectable NT Ab titer: a titer ≥ 10 (1/dil) on Day 01, Day 22, Day 43, Day 202
|
Day 01, Day 22, Day 43, Day 202
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年8月3日
一次修了 (推定)
2028年2月22日
研究の完了 (推定)
2028年2月22日
試験登録日
最初に提出
2026年7月31日
QC基準を満たした最初の提出物
2026年8月19日
最初の投稿 (実際)
2026年8月21日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月11日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- VBX21138
- U1111-1325-2670 (レジストリ識別子：ICTRP)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。